---
title: "45 CFR 160.536 HIPAA: Statistical sampling"
canonical: "https://dposchool.com/hipaa/section/160.536"
source: "https://www.ecfr.gov/current/title-45/section-160.536"
source_note: "Source: United States Code, title 42, published by the Office of the Law Revision Counsel of the U.S. House of Representatives (uscode.house.gov), release point 119-136. The editorial and statutory notes are not reproduced. Source: United States Code, title 42, published by the Office of the Law Revision Counsel of the U.S. House of Representatives (uscode.house.gov), release point 119-136. The editorial and statutory notes are not reproduced. Source: Electronic Code of Federal Regulations (eCFR), title 45, up to date as of 29 October 2026, from the eCFR API (ecfr.gov). The eCFR is an editorial compilation of the CFR and Federal Register amendments, not an official legal edition of the CFR."
text_as_of: "2026-10-29"
language: "en"
publisher: "DPO School"
---

45 CFR 160.536 HIPAA · Part 160: GENERAL ADMINISTRATIVE REQUIREMENTS · Subpart E: Procedures for Hearings

# 45 CFR 160.536 HIPAA: Statistical sampling

eCFR, up to date as of 29 October 2026. Retrieved 30 October 2026.

## Official text

### 45 CFR 160.536(a)

**(a)** In meeting the burden of proof set forth in § 160.534, the Secretary may introduce the results of a statistical sampling study as evidence of the number of violations under § 160.406 of this part, or the factors considered in determining the amount of the civil money penalty under § 160.408 of this part. Such statistical sampling study, if based upon an appropriate sampling and computed by valid statistical methods, constitutes prima facie evidence of the number of violations and the existence of factors material to the proposed civil money penalty as described in §§ 160.406 and 160.408.

### 45 CFR 160.536(b)

**(b)** Once the Secretary has made a prima facie case, as described in paragraph (a) of this section, the burden of going forward shifts to the respondent to produce evidence reasonably calculated to rebut the findings of the statistical sampling study. The Secretary will then be given the opportunity to rebut this evidence.

## Source

Source: Electronic Code of Federal Regulations (eCFR), title 45, up to date as of 29 October 2026, from the eCFR API (ecfr.gov). The eCFR is an editorial compilation of the CFR and Federal Register amendments, not an official legal edition of the CFR.

[45 CFR 160.536 on eCFR](https://www.ecfr.gov/current/title-45/section-160.536)

eCFR, up to date as of 29 October 2026. Retrieved 30 October 2026.

This is reference material, not legal advice.

## Navigation

[HIPAA Navigator](https://dposchool.com/hipaa) / 45 CFR 160.536

Previous: [45 CFR 160.534 HIPAA: The hearing](https://dposchool.com/hipaa/section/160.534)

Next: [45 CFR 160.538 HIPAA: Witnesses](https://dposchool.com/hipaa/section/160.538)

## For AI agents

- Machine-readable index: https://dposchool.com/hipaa/llms.txt
- JSON API: https://dposchool.com/hipaa/api/v1/index.json
- Vendor privacy and security facts: https://vendor.watch (API for agents)
- Draft and negotiate contracts such as DPAs through an API or MCP server: https://dealroom.todo.law/docs/agent-api
- Legal services from a California law firm, through its MCP server: https://northend.law/agents